Ever wondered how the pharmaceutical companies test the drug before releasing it in the market? There are several stages of testing and observations for each drug that a pharmaceutical company develops. Conducting these studies within the lab (in vitro) and in living organisms (in vivo) is not all that simple. The in vitro processes do not need stringent protocols or planning. However, after submitting positive results, under the observation of experts, the medicine will step to the next phase, which is more complex and at times risky, i.e., testing the drug on animals and humans.
A pharmaceutical company will usually hire a contract research organization (CRO) to complete this phase. A CRO is a company that provides its services to the pharmaceutical firm, whether it is to conduct the testing on the subject or for preparing the intense paper work, which have to be filed adequately for the government’ s approval. CROs can take up the agreement with firms outside the country as well. This way, the pharmaceutical company can reduce the costs incurred by outsourcing the CROs services in an underdeveloped or developing country. This method is only employed to reduce the costs of making the drugs only and not to cheat or take advantage of the poorer countries. Hence, the tests are conducted in the supervision of the officials of the subcontracting country.
In order to release a medicine or drug in to the market, there are some tests to be conducted over voluntary patients who suffer from the disease. Stability USP dissolution test is one such study, where the drug is introduced into the patient and tested under various conditions. Then the metabolism of the patient is put under observation. Until the drug is excreted, all the changes taking place within the patients’ body are noted. These observations and results are studied by experts, who will in turn advice the authorities whether the drug should be released into the market or not.
It is witnessed that a particular drug acts differently under different conditions. Suppose you give a patient a certain amount or quantity of the medicine in the form of a capsule, it will show a set of readings. The same drug when consumed in the form of a tablet will show a different set of evaluations. Hence, USP dissolution tests will check the stability of the drug with respect to the mode of intake as well. Therefore, stability USP dissolution tests are significant in the field of medicine and have been described as a major gizmo to characterize a drug product enactment.
Pharmacokinetics, a branch of pharmacology, is concerned with the determination of the fate of externally administered substances (mostly chemical) to a living organism. By definition and in principle as well, it deals with all kinds of compounds – such as hormones, metabolites, toxins and even nutrients – that are ingested by an organism or delivered to it in external forms. However, in practice the application of this discipline is mainly pharmaceutical, that is, concerned with drug substances.
The discipline describes the body’s affects on a specific drug post-administration – how the drug is acted upon by the biochemicals (enzymes, for example) and the speed of such processes. Thus it is classified into these aspects of drug-body interaction, viz., the extent and rate of Absorption (of substances of drug entering blood circulation), Distribution (of substances through body fluids and tissues), Metabolism (or irreversible transformation of parent compounds into daughter metabolites) and Excretion (of substances from the body). This is popularly termed as the ADME scheme.
Recent developments in the study of drug-body interactions suggest the inclusion of the new term, Liberation (of substances from the drug from the formulation, on entering the body). In view of this, Pharmacokinetics begins to deal with the LADME scheme. For the purpose of study, pharmacokinetics is often combined with pharmacodynamics.
One of the deadly and lethal diseases ever effected the mankind is Cancer. Breast Cancer is one such cancer, which effects women and history seen a reasonable number of patients suffering with this malignancy. There are various types of breast cancers, namely, holistic, conventional, alternative, and natural ways. The patient would experience lots of pain and imbalance, which can be treated with a timely surgery, radiation therapy or chemotherapy.
Due to the advancements in the field of science and medicine, there is a better way to treat breast cancer; it is called as personalized anticancer therapy. The personalized anticancer therapy allows the patient to a periodical anticancer treatment at home at their convenience. The main advantage of the personalized anticancer therapy is that it is very simple and does not involve any radiation treatments.
A personalized anti cancer therapy kit can be purchased at any medical store. You could consult your family doctor to help you learn how to use the personalized anticancer therapy kit in an effective way. You can also follow an anti-cancer diet as recommended by the doctor, so that the treatment will have positive effects. A personalized anticancer therapy is recommended as transparent therapy to handle breast cancer for women.
Living organisms, on being introduced to pharmaceutical substances, modify them biochemically through specialized enzymatic systems. The study of the processes during the interaction of the organism and the drug, called drug metabolism, is possible through in vitro (in the test tube, or at the laboratory) simulations of in vivo (in the living organism) conditions as well as direct in vivo tests.
In vitro drug metabolism is often observed in a human-derived sample preparation. Its advantages over the in vivo study are three fold: it saves time; reduces the dependence on use of live animals; and provides the contrivances to investigate the specificity of the metabolic disposition of a compound.
The laboratory approach of in vitro metabolism gets more feasible when a large number of compounds are available, especially in small amounts. It is too difficult for them to be used up for in vivo testing, as the metabolism is less visible and least controlled in this case. Apart from eliminating the need to execute several unethical and expensive clinical drug interaction studies, in vitro testing is an important prerequisite for the in vivo procedure as testing on human tissue and the associated recombinant human enzymes can be useful for further drug development.
Man is faced with different health problems each day, thus making him to seek medical aid to cure his illness. Because of several new diseases and problems, the hospital or clinic should be medically equipped to treat patients quickly. Some establishments are low on budget and cannot afford costly and latest medical equipment. For such institutions, clinical equipment rental would be the right choice.
A clinical equipment rental will provide flexibility for the hospital to temporarily lease out costly and complicated equipment for specific patients who will require its assistance. There are a few advantages of the clinical equipment rental approach. Instead of investing for the entire equipment, a clinical equipment rental will only incur the lease amount. This will save a lot of money on the hospital’s part and at the same time provides adequate medical attention to the patient.
Another big advantage of clinical equipment rental is that you need not purchase and house costly equipment, which is occasional utilized; thereby preventing inventory costs of the machine. The machine will be leased as and when the demand arises and will be sent back to the dealer, after its purpose is served. Some of the main clinical equipment rentals are CT scanner, centrifuge machine, sonogram, x-ray film processing, endoscope, MRI scanner etc.
The biomarkers that indicate exposure to a variety of environmental substances in the fields of epidemiology and toxicology are well-detected through the popular method of Enzyme-Linked Immunosorbent Assay (ELISA).
For example, exposure to endocrine pollutants in fish is tested through the appropriately sensitive biomarkers Vitellogenin (Vtg, the proteins in egg yolk), Zona radiata proteins (Zrp, present in the egg shell), Metallothionein ( or MT) and Cytochrome P450 1A (CYP1A).
The ELISA biomarker kit is semi-quantitative, meaning the assay protocol is unsuitable to quantify exact amounts of biomarkers concerned. It contains a set of reagents that are to be used along with the respective primary antibody for semi-quantitative evaluation of biomarkers like Vtg, Zrp, Mt and CYP1A in fish samples.
The assay’s principle lies in the identification of the biomarker through either a respective monoclonal or a polyclonal antibody in an indirect antibody capture ELISA arrangement. In this procedure, a purified biomarker protein (such as purified Vtg) or a standard positive sample is used for comparison as a positive control.
This kit is essential in procedures of environmental investigation and effluent observation. The assay is also used in consolidation with other standard fish tests, in obedience to the OECD Guidelines for Testing of Chemicals.
The biomarker ELISA kit comes in two sizes, with different reagent quantities – adequate to run 1 plate (or 96 wells), or 5 plates (480 wells).
In any clinical research, a sample of blood or tissue will be taken from the specimen and then will be processed as a genetic analysis study. The involvement of the subject will be only to produce the sample, where the sample is the essential link among the subject, his/her medical records and the obtained medical report. The report is generated after performing sufficient genetic analysis on his/her sample.
The sample will be secured and not disclosed to anyone else, apart from the subject and his/her close relative (that too if the patient insists), the researcher, who has done the genetic analysis and sponsors for the research. All medical samples will be stowed, cooled, archived and sent to researchers. The privacy of the patient is maintained and is given utmost priority. Other procedurals, such as access to the sample, discovery of the gene, drug development and registration of the product are strictly kept secluded only for the concerned personnel. Therefore, there is a strict vigilance on the passing of information in this perspective.
The clinical samples collected are stored for specific processes and trials. The results obtained by these trials are then shared with the government authorities, who will give away orders to develop new and better medications.
The assessment is based on toxicity investigation of electrophiles (organochlorines, compounds with an activated double bond and epoxides) on the biological nucleophiles – DNA and GSH (Glutathione).
Genetically modified Escherichia coli strains provide nucleophiles on which varied bioanalytical assays are run and properties of specific reactivity and cytotoxicity in each case are recorded.
Cellular GSH depletion and growth inhibition of a GSH-deficient strain are performed to investigate importance of GSH for detoxification. Induction of DNA repair systems, DNA fragmentation and growth inhibition of strain deficient in major DNA repair mechanisms are measured to test for DNA damage.
The sets of strains that lack either GSH or DNA repair along with their respective parent strains are the most suitable bioanalytical assays for detection of mechanisms causing the evident cytotoxicity of the screened electrophiles. When compared for toxicity, they indicate three distinct ways of toxicity on electrophiles – DNA damage, GSH depletion-related toxicity and Unspecific reactivity.
While epoxides 1,2-epoxybutane, (2,3-epoxypropyl)benzene and styrene oxide are the chemical group with DNA damage-related toxicity, those with toxicity resulting in GSH depletion include compounds with an activated double bond such as acrylates and acrolein. These two classes are linked with respective toxicities, whereas all reactive organochlorines and certain epoxides are classified as unspecifically reactive, owing to their toxicity being initiated by reactions with both the bio-nucleophiles.
There are several research academies and laboratories that are performing various tests and studies to cure cancer. Even when the technology combined with medicine has produced miraculous results with other diseases, cancer seems to be unmoved, despite the efforts of several experts. The present patient derived tumor xenograft efficacy models are depending on the cell lines of diseased patients. Even though they are considered to be an ideal choice for conducting basic level research or experiments, they do not give a high efficacy. This has in turn resulted in a slight setback, which means the patient derived tumor xenograft efficacy models are not always effective for clinical research, however they are important to carry on the tests to advanced phases.
In the patient derived xenograft models, a small quantity of tumor is derived from the sufferer and injected into the immune deficient mice. Then the various drugs are tested against the malignances. This way the tests must offer some concrete results, which are otherwise not possible by usage of commercial cells. Moreover, the patient derived tumor xenograft efficacy models are used to screen and select drugs and drug products for other in vivo assessments. Hence, this test is more like a stepping stone to the larger and more practical tests, where the tests will be conducted over live patients.